Kornimate/medical-research-clean huggingface dataset:
seprafilm® for prevention of adhesions at repeat cesarean

Conditions: Adhesion Formation After Primary Cesarean Delivery

Summary: adhesion formation is a result of abdominal and pelvic surgery and is a cause of such diseases as chronic pain syndrome, bowel obstruction and infertility. both patients and surgeons suffer when adhesions are encountered, since the surgery becomes more intense, lengthy, and complicated. seprafilm® has been shown to limit the formation of adhesions in gynecologic and abdominal surgery. limited data is available on the effectiveness of seprafilm® in the prevention of abdominal wall and pelvic adhesions at the time of cesarean section. adhesions at the time of repeat cesarean make the surgery frustrating and complex, with difficult lysis of adhesions being the cause of morbidities such as bladder damage, increased blood loss, and longer operating times. the objective of this definitive project is to define the extent of reduction of adhesion formation of seprafilm® when used at the time of primary cesarean section. women undergoing primary cesarean section will be randomized for seprafilm® application, and the incidence and grade of adhesions at repeat cesarean will be determined.

this is a prospective randomized double-blinded study. patients will be randomized prior to primary cesarean section to either the study arm (seprafilm® placement) or control arm (nothing placed). seprafilm® will be placed over the repaired uterine incision and over the anterior aspect of the uterus prior to closure of the fascia (2 to 3 sheets per patient). randomization will be by opaque envelops containing group assignment. participants and surgeons will be blinded to group designation at the time of repeat cesarean. the surgeon will be asked to grade the adhesions at the time of repeat cesarean.

Eligibility criteria:
inclusion criteria: 1. pregnant women after 24 weeks' gestation. 2. first cesarean delivery. 3. age \> 18 years. 4. cesarean to be performed by a participating surgeon. 5. non-closure of the visceral or parietal peritoneum. exclusion criteria: 1. any prior abdominal surgery including prior cesarean, laparoscopy, appendectomy, cholecystectomy or any uterine adnexal or bowel surgery. 2. clinical diagnosis of chorioamnionitis. 3. women having tubal ligation at the time of primary cesarean. 4. inability to obtain informed consent.

Keywords: seprafilm® cesarean adhesions primary repeat
effect of selective and nonselective cyclooxygenase enzyme inhibition on arterial blood pressure and cerebral blood flow with exposure to intermittent hypoxia in humans

Conditions: Obstructive Sleep Apnea; Hypertension; Cardiovascular Diseases; Stroke

Summary: the study has been designed to assess the effect of cyclooxygenase inhibition on blood pressure, cerebral blood flow, ventilation and renal hemodynamics following chronic intermittent hypoxia exposure.

the study will specifically evaluate: 1. cardiovascular effect of cyclooxygenase inhibitors on cerebral, vascular, blood pressure and homeostatic responses following chronic intermittent hypoxia exposure. 2. ventilatory response of cyclooxygenase inhibitors following chronic intermittent hypoxia exposure 3. evaluate the renal hemodynamic effect of chronic intermittent hypoxia exposure and cyclooxygenase inhibition.

Eligibility criteria:
inclusion criteria: * healthy male subjects * 18 - 45 years of age * informed written consent exclusion criteria: * any history of cardio-respiratory diseases, ongoing medication, smoking, trauma, acute illnesses, collagen vascular diseases, rheumatoid arthritis, osteoarthritis

Keywords: obstructive sleep apnea hypoxia sleep blood pressure hypertension myocardial infarction stroke ventilation brain cerebral blood flow renal blood flow
study examining the effects of mindfulness and similar audio-guided exercises.

Conditions: Mindfulness; Healthy Population

Summary: this study aims to examine whether greater length of mindfulness practice results in more beneficial outcomes.

this study will randomise participants to one of three groups: (1) four sessions of medium length mindfulness practice (lasting 20 mins) and 5 mins of an audio book; (2) four sessions of brief mindfulness practice (lasting 5 mins) and 20 mins of an audio book; and (3) a control group who just receive 4 sessions of audio book (lasting 25 mins). in the mindfulness arms, in each session, the participants will receive the audio book prior to the mindfulness practice. mindfulness levels, and depression, anxiety and stress will be measured by self-report at baseline, session by session, and at post-intervention.

Eligibility criteria:
inclusion criteria: * members of the general public, especially university students or staff. * adequate understanding of spoken and written english exclusion criteria: * currently experiencing significant difficulties with their mental wellbeing. * currently have a personal mindfulness practice. * currently participating in a mindfulness-based intervention.
pharmacokinetics of kbp-5074 in patients with moderate hepatic impairment

Conditions: Moderate Hepatic Impairment; Healthy

Summary: this multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (child-pugh class b) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (pk) of kbp-5074.


Eligibility criteria:
key inclusion criteria: 1. males or females, of any race, between 18 and 80 years of age, inclusive, at screening. 2. body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening. 3. subjects with normal hepatic function must be in good health. 4. subjects must meet the criteria for moderate hepatic impairment based on child pugh b. key exclusion criteria: 1. significant history or clinical manifestation of any medical history, as determined by the investigator not appropriate to participate in this study. 2. positive serology test results for hepatitis b surface antigen and/or human immunodeficiency virus 1/2. 3. participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives prior to dosing, whichever is longer. 4. use of mineralocorticoids or mras (eg, spironolactone or eplenerone) within 90 days prior to study drug administration, unless deemed acceptable by the medical monitor and sponsor. 5. subject has used prescription drugs within 30 days of study drug administration, with the exception of established therapy for hepatic disease and the treatment of associated disorders that have been stable for at least 30 days before study drug administration, as approved by the investigator and in consultation with the medical monitor.

Keywords: hepatic impairment moderate hepatic impairment healthy kbp-5074
creating a laparoscopic banded sleeve gastrectomy

Conditions: Morbid Obesity

Summary: a sleeve gastrectomy (sg) is on the long term not always successful in every patient because weight regain can occur. an intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the sleeve (banded-sleeve gastrectomy: bsg) which increases weight loss and decreases weight regain on the longer term. the question is whether primary application of a banded sleeve gives a greater weight loss and / or prevent weight regain in the future versus a standard sleeve gastrectomy.

a sleeve gastrectomy (sg) is on the long term not always successful in every patient because weight regain can occur. an intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the sleeve (banded-sleeve gastrectomy: bsg) which increases weight loss and decreases weight regain on the longer term. the question is whether primary application of a banded sleeve gives a greater weight loss and / or prevent weight regain in the future versus a standard sleeve gastrectomy. study is a prospective, randomized, multi centre trial. study population: patients who qualify for a sg are eligible to participate. the primary sg patients may participate if there is a bmi of 35 kg / m2 with a morbidly obesity-related comorbidity or a bmi of 40kg / m2 or higher. intervention: the standard sg is compared with a banded-sg (bsg)

Eligibility criteria:
inclusion criteria: * alle patients who are eligible for a primary sg exclusion criteria: * bariatric surgery in medical history * bmi \> 60kg/m2 or a planned two-stage procedure. * patients with a language barrier which may affect the compliance with medical advice * patients with a disease not related to morbid obesity, such as cushing or drug related. * chronic bowel disease for example crohn's disease or colitis colitis. * renal impairment (mdrd \<30) or hepatic dysfunction (liver function twice the normal values) * pregnancy during follow-up * patients with treatment-resistant reflux symptoms. defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors
study on the applicability of ccr criteria in rectal cancer

Conditions: PMMR/MSS Adenocarcinoma of the Colon or Rectum; Neoadjuvant Chemoradiotherapy; Immunotherapy; Complete Response

Summary: this study aims to explore how well the usual ways of checking if rectal cancer patients are free of disease signs after treatment work for a new treatment method. the new method combines chemotherapy, radiation, and immune-boosting drugs before surgery. we know these usual ways work for the standard treatment, but we're not sure if they're good enough for this new combo treatment. we'll look at patients with a specific type of rectal cancer that doesn't respond well to just immune-boosting drugs alone. by comparing how patients treated with the new method and the old method respond, we hope to find better ways to tell if the treatment is really working, which could help improve treatment plans for these patients.


Eligibility criteria:
inclusion criteria: 1. histopathologically confirmed adenocarcinoma; 2. pmmr/mss tumors; 3. clinical staging of t3-t4 or any lymph node-positive t (n+); 4. no evidence of distant metastasis based on radiological examinations; 5. treatment with long-course chemoradiotherapy (lcrt) with or without immune checkpoint inhibitors (ici); 6. post-neoadjuvant therapy evaluation with endoscopy and pelvic mri. exclusion criteria: 1. presence of other active malignancies; 2. having severe comorbidities, such as heart failure, severe hepatic or renal insufficiency, etc; 3. lack of imaging and endoscopic examinations; 4. treatment plan does not meet the study requirements.
stationary bike study

Conditions: Vertigo; Concussion; Dizziness

Summary: investigators will use a stationary bike protocol to investigate whether patients with post concussion syndrome benefit from adding exertion training to a vestibular rehabilitation program. investigators examine the effect of aerobic exercise testing and training on individuals with concussion who are currently experiencing symptoms and examine the effect of aerobic exercise in combination with traditional vestibular rehabilitation.

this is a randomized controlled single blind pilot study testing the hypothesis that the combination of aerobic exercise plus vestibular rehabilitation will result in greater reduction of symptoms of dizziness and imbalance compared to vestibular rehabilitation alone.

Eligibility criteria:
inclusion criteria: 1. history of concussion \>14 days, \<6 months 2. one or more of the following symptoms after most recent head injury: headache, dizziness, fatigue, irritability, insomnia, concentration or memory difficulty) 3. age range - 18-70 4. access to stationary bicycle 5. ability to read and write sixth grade english exclusion criteria: 1. inability to participate in aerobic exercise for any reason 2. pre-existing or current neurological or autonomic disease including persistent symptoms form previous concussion 3. major depressive disorder 4. litigation 5. increased cardiac risk 6. currently taking, beta blockers, or anticonvulsants

Keywords: vestibular rehabilitation
effects of a single dose of amisulpride on functional brain changes

Conditions: Major Depressive Disorder

Summary: this study is designed to investigate effects of a single dose of amisulpride on functional brain changes during reward- and motivation-related processing and at rest in healthy volunteers (hv) and in patients with major depressive disorder (mdd).

double blind, placebo-controlled, randomized, single dose, parallel-group design the study is designed to investigate effects of a single dose of amisulpride on functional brain changes during reward- and motivation-related processing and at rest. measurement of functional brain changes will occur after a single dose of amisulpride or placebo in hv and patients with mdd. it is hypothesized that functional brain changes previously linked to reward- and motivation-related processing require dopaminergic signaling and are diminished in mdd compared to hv. in mdd, but not in hv, treatment with a single low dose (100 mg) amisulpride should increase brain activation associated with reward- and motivation-related processing. to test these hypotheses, we will implement a randomized, placebo-controlled, parallel- group design with 4 treatment arms (mdd/placebo, mdd/amisulpride, hv/placebo and hv/ amisulpride). all subjects will undergo mri scanning sessions at visit 3 and visit 4. treatment with amisulpride or matching placebo will occur 3.5 to 4 hours before the start of each scanning session. time of treatment will be standardized across subjects. at visit 3 and visit 4, blood samples will be taken 30 minutes pre-dose, and 1 hour, 3.5 to 4 hours, and 4.5 to 5 hours after oral drug administration to determine target plasma levels of amisulpride. the study is composed of 4 outpatient visits: screening, baseline and 2 scanning sessions.

Eligibility criteria:
mdd patients: inclusion: * male and female patients with mdd; aged 18 to 45 years * montgomery-åsberg depression rating scale (madrs) score \> 7 and \<26 at screening. exclusion: * meeting diagnostic criteria for any major psychiatric disorder (other than mdd), as determined by dsm-5 at screening. * having received prescribed medication (including antidepressants (ad)) within 14 days or fluoxetine within 90 days prior to visit 3 (apart from the contraceptive pill). * having received psychotherapy within 14 days prior to visit 3. * positive severe acute respiratory syndrome coronavirus type 2 (sars-cov-2) test. healthy volunteers: inclusion: * healthy * aged 18 to 45 years exclusion: * meeting diagnostic criteria for any major psychiatric disorder. * a history of psychiatric or neurologic disorders. * having received prescribed medication within 14 days prior to visit 3 (apart from the contraceptive pill). * positive sars-cov-2 test.

Keywords: major depressive disorder amisulpride functional brain changes bold responses
a study of participants with relapsing-remitting multiple sclerosis (rrms)

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: to look at the ability of ly2127399 to reduce magnetic resonance imaging (mri) lesions at 12, 16, 20, and 24 weeks compared to placebo.


Eligibility criteria:
inclusion criteria: * 18 through 64 years of age diagnosed with rrms, who can walk without aid or rest for at least 200 meters (approximately 1/10 of a mile). * women who can become pregnant must use birth control. exclusion criteria: * have had a live vaccination within 12 weeks before randomization, or intend to have a live vaccination during the course of the study. * have had had recent surgery or are scheduled to have surgery during the study. * are immunocompromised or have evidence of active infection \[such as hepatitis, tuberculosis or, human immunodeficiency virus (hiv)\]. * have been on certain drugs that are being studied for rrms or have recently received prescription drugs to treat rrms. * have had a recent serious infection. * have serious or uncontrolled illnesses other than rrms. * have clinically significant blood test values. * have multiple or severe drug allergies. * have contraindications for mri "scanning" or claustrophobia (fear of an enclosed space) that cannot be managed.

Keywords: relapsing remitting multiple sclerosis multiple sclerosis ms ly2127399
the effect of aerobic exercise on lower urinary system symptoms in women with diabetes mellitus

Conditions: Lower Urinary Tract Symptoms; Diabetes Mellitus, Type 2

Summary: the goal of this clinical trial is to investigate the effect of aerobic exercise (ae) on bladder functions and urinary system symptoms in women diagnosed with diabetes mellitus (dm) and suffered from lower urinary tract symptoms (luts). in the study, 44 individuals (35-55 age) were divided into two groups: aerobic exercise (ae) (n=22) and control group (n=22) by simple random method. the main questions it aims to answer are: * is aerobic exercise effective on bladder functions in women diagnosed with diabetes mellitus and suffered from lower urinary tract symptoms? * is aerobic exercise effective on urinary tract symptoms in women diagnosed with diabetes mellitus and suffered from lower urinary tract symptoms? * is aerobic exercise effective on quality of life in women diagnosed with diabetes mellitus and suffered from lower urinary tract symptoms? intervention/treatment * control group individuals will be given a behavioral treatment program. * submaximal aerobic exercise training will be given to the ae group in addition to the behavioral treatment program.

the goal of this clinical trial is to investigate the effect of aerobic exercise (ae) on bladder functions and urinary system symptoms in women diagnosed with diabetes mellitus (dm) and suffered from lower urinary tract symptoms (luts). in the study, 44 individuals (35-55 age) were divided into two groups: aerobic exercise (ae) (n=22) and control group (n=22) by simple random method. bladder sensation (first sensation) and compliance from urodynamic evaluations will be taken as reference as the primary outcome measurement in treatment effectiveness. * control group individuals will be given a behavioral treatment program. * submaximal aerobic exercise training will be given to the ae group in addition to the behavioral treatment program. ae training was provided three days a week, 45 minutes a day, for 12 weeks. the behavioral treatment protocol was completed with an initial training period of 40 minutes, and subsequent control interviews of 20 minutes at four-week intervals.

Eligibility criteria:
inclusion criteria: * women between the ages of 35-55, * individuals who volunteer to participate in the study, * those diagnosed with type ii diabetes for 5 years or more and those diagnosed with luts exclusion criteria: * stage 2 and more advanced pelvic organ prolapse, * urinary tract infection, * has had previous surgery for urinary incontinence and pelvic organ prolapse, * diagnosis of cerebro vascular event (cve) and dementia, * using a-blockers, antimuscarinics, antidepressants, diuretics and antihistamines, * individuals in menopause.

Keywords: lower urinary tract symptoms diabetes mellitus, type 2 bladder aerobic exercise quality of life
comparative efficacy and safety study in patients with ulcerative colitis in remission phase

Conditions: Ulcerative Colitis in Remission

Summary: to demonstrate that import mesalazine (asacol®) is non-inferior to the reference drug, marketed mesalazine, regarding the primary endpoint (rate of non-emergence of bloody stool), in patients with ulcerative colitis in remission, treated for 48 weeks.


Eligibility criteria:
inclusion criteria: * patients with ulcerative colitis in remission who are defined to show an ulcerative colitis-disease activity index (uc-dai) score of 2 or less and a bloody stool score of 0. exclusion criteria: * patients who take adrenal corticosteroid (oral formulation, enemas, suppository, agents for hemorrhoidal disease, injectable solution) within 14 days before start of administration of clinical study drug.
diaphragm ultrasound in weaning from mechanical ventilation

Conditions: Abdominal Sepsis

Summary: this study aims to evaluate the efficacy of ultrasound derived variables in prediction of success of weaning from mechanical ventilation in critically ill patients with abdominal sepsis

difficult weaning from mechanical ventilation (mv) is a common problem in critically ill patients. many parameters have been developed to aid weaning from mv such as p/f ratio (po2/fio2) and rapid shallow breathing index (respiratory rate/tidal volume); however, sensitivity and specificity for most variables are still variable in literature. diaphragmatic dysfunction is a common cause of weaning failure (2) however most of the traditional methods used for evaluation of diaphragmatic function (fluoroscopy, trans-diaphragmatic pressure measurement) are invasive and not available. ultrasound assessment of diaphragmatic function has been developed recently providing an easy and safe method for evaluation of diaphragmatic excursion and thickening. in this study we will evaluate the ability of the diaphragmatic function to predict weaning success in patients with abdominal sepsis. after weaning, patients will be divided into two groups; group of successful weaning (group s) and group with failed weaning (group f) both groups will be compared as regards all clinical, laboratory, and ultrasonographic parameters recorded before weaning, further analysis will be done for patients with repeated trials of weaning (more than one trial or more than one week mv) and those with simple weaning (first time for weaning). a 7-10 mega hertz linear ultrasound probe (mindray machine) set to b mode, the diaphragm will be visualized by placing the transducer perpendicular to the chest wall, in the eighth or ninth intercostal space, between the anterior axillary and the midaxillary lines, to observe the zone of apposition of the muscle 0.5 to 2 cm below the costophrenic sinus. the diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line. then, the diaphragmatic fraction thickening (dtf) will be calculated as percentage diaphragmatic movement will be measured in all patients with a 3.5 mega hertz us probe placed over one of the lower intercostal spaces in the right anterior axillary line for the right diaphragm and the left midaxillary line for the left diaphragm.

Eligibility criteria:
inclusion criteria: * critically ill patients with abdominal sepsis with history of mv for more than 48 hours exclusion criteria: * age \< 18 years and surgical dressings over the right lower rib cage which would preclude ultrasound examination will be excluded. also, patients with chest trauma, thoracotomy, diaphragmatic paralysis, diaphragmatic dysfunction, diaphragmatic injury, diaphragmatic surgery and patients with neuromuscular diseases